15 mg, 30 mg, and 45 mg film-coated tablets
dacomitinib
What Vizimpro is and what it is used for
Vizimpro contains the active substance dacomitinib, which belongs to a group of medicines called protein tyrosine kinase inhibitors used to treat cancer.
Vizimpro is used to treat adults with a type of lung cancer called non-small cell lung cancer. If a test has shown that your cancer has certain changes ( mutations ) in a gene called EGFR ( epidermal growth factor receptor) and has spread to your other lung or other organs, your cancer is likely to respond to treatment with Vizimpro.
Vizimpro can be used as the first treatment when your lung cancer has spread to your second lung or other organs.
What you need to know before you take Vizimpro
Do not take Vizimpro
- if you are allergic to dacomitinib or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Vizimpro:
- if you have ever had other lung problems. Some lung problems may worsen when treated with Vizimpro because Vizimpro can cause inflammation in the lungs during treatment. The symptoms can be similar to those of lung cancer. Tell your doctor immediately if you develop new or worsening symptoms, such as difficulty breathing, shortness of breath, cough with or without phlegm, or fever.
- if you are being treated with any of the medicines listed in the Other medicines and Vizimpro section.
Inform the doctor immediately when taking this medicine:
- if you get diarrhea. Diarrhea must be treated immediately.
- if you get a rash. Treatment of skin rashes must be started early.
- if you get symptoms of liver problems, e.g. yellow-colored skin or whites of the eyes (jaundice), dark or brown (tea-colored) urine, or light-colored stools.
Children and young people
Vizimpro has not been studied in children and adolescents and must not be given to patients under 18 years of age.
Other medicines and Vizimpro
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is important because some medicines can have an enhanced effect if taken together with Vizimpro. This applies, among other things:
- procainamide, which is used for irregular heart rhythms
- pimozide and thioridazine, used in schizophrenia and psychosis.
You should not take these medicines while you are being treated with Vizimpro.
The following medicines may reduce the effect of Vizimpro:
- Long-acting medicines to reduce the amount of stomach acid, e.g. proton pump inhibitors (for stomach ulcers, indigestion, and heartburn).
You should not take these medicines while you are being treated with Vizimpro. Instead, you can take a short-acting medicine, such as an antacid or a medicine called an H2 blocker. If you take H2 blockers, take your dose of Vizimpro at least 2 hours before or 10 hours after taking the H2 blocker.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You must not have children during treatment with Vizimpro. This medicine can harm the fetus. If there is any risk that you could become pregnant, you must use effective contraception during treatment and for at least 17 days afterward. Contact your doctor immediately if you become pregnant while taking this medicine.
Breast-feeding
You should not breastfeed while taking this medicine because it is not known whether it can harm the baby.
Driving ability and use of machinery
Fatigue and eye irritation may occur in patients taking Vizimpro. If you feel tired or if your eyes are irritated, be careful when driving any vehicle or using machinery.
Vizimpro contains lactose and sodium
This medicine contains lactose (found in milk and dairy products). If you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to use Vizimpro
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
- The recommended dose is 45 mg by mouth every day.
- Take the tablet at about the same time each day.
- Swallow the tablet whole with a glass of water.
- You can take the tablet with or without food.
The doctor may reduce the dose of this medicine depending on how well you tolerate it.
If you have taken too much Vizimpro
If you have taken too much Vizimpro, see a doctor or go to the hospital immediately.
If you forget to take Vizimpro
If you miss a dose or vomit it up, take the next dose as planned. Do not take a double dose to make up for a missed tablet.
If you stop taking Vizimpro
Do not stop taking Vizimpro unless your doctor tells you to. If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact the doctor immediately if you experience any of the following side effects – you may need urgent medical treatment:
- Inflammation of the lungs (common, may affect up to 1 in 10 people)
Breathing problems, shortness of breath, possibly with cough or fever. This may indicate an inflammation of the lungs called interstitial lung disease, which can be fatal.
- Diarrhea (very common, may affect more than 1 in 10 people)
Diarrhea can lead to dehydration (common), low potassium in the blood (very common), and impaired lung function, and can lead to death. At the first sign of more frequent bowel movements, contact the doctor immediately, drink plenty of fluids and start anti-diarrhea medication as soon as possible. Before you start taking Vizimpro, you should have anti-diarrhea medicine at home.
- Skin rash (very common)
The rash must be treated early. Tell your doctor if you get a rash. If the treatment for the rash does not work or the rash worsens (if your skin e.g. flakes or cracks), tell the doctor immediately. The doctor may decide that you should stop treatment with Vizimpro. Skin rashes may appear or worsen in areas exposed to the sun. The use of protective clothing and sunscreen is recommended.
Tell your doctor as soon as possible if you get any of the following side effects:
Very common (may affect more than 1 in 10 people):
- Inflammation in the mouth and lips
- Problems with the nails
- Dry skin
- Loss of appetite
- Dry, red, or itchy eyes
- Weight loss
- Hair loss
- Itching
- Abnormal liver enzymes in blood tests
- Nausea or vomiting
- Reddened or painful palms or soles of feet
- Fatigue
- Weakness
- Skin cracks
Common (may affect up to 1 in 10 people):
- Taste changes
- Scaly skin
- Eye inflammation
- Abnormal body hair
How to store Vizimpro
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and blister pack after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
This medicine may pose a risk to the environment. Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is dacomitinib (as dacomitinib monohydrate). Vizimpro tablets are available in different strengths. Vizimpro 15 mg tablet: each tablet contains 15 mg dacomitinibVizimpro 30 mg tablet: each tablet contains 30 mg dacomitinibVizimpro 45 mg tablet: each tablet contains 45 mg dacomitinib
- Other ingredients are Tablet core: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate (see section 2 Vizimpro contains lactose and sodium ).Film coating: Opadry II blue 85F30716 containing polyvinyl alcohol – partially hydrolyzed (E1203), talc (E553b), titanium dioxide (E171), macrogol (E1521), indigo carmine aluminum lake (E132).
Appearance and package sizes of the medicine
- Vizimpro 15 mg film-coated tablets are blue, film-coated, round, biconvex tablets debossed with “Pfizer” on one side and “DCB15” on the other side.
- Vizimpro 30 mg film-coated tablets are blue, film-coated, round, biconvex tablets debossed with “Pfizer” on one side and “DCB30” on the other side.
- Vizimpro 45 mg film-coated tablets are blue, film-coated, round, biconvex tablets debossed with “Pfizer” on one side and “DCB45” on the other side.
They are available in blister packs of 30 film-coated tablets (tablets).
Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg
Germany
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| België/Belgique/BelgienLuxembourg/LuxembourgPfizer NV/SATel/Tel: +32 (0)2 554 62 11 | LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel. + 370 52 51 4000 |
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| DenmarkPfizer ApSPhone: +45 44 20 11 00 | The NetherlandsPfizer BVPhone: +31 (0)10 406 43 01 |
| DeutschlandPFIZER PHARMA GmbHPhone: +49 (0)30 550055-51000 | NorwayPfizer iPhone: +47 67 52 61 00 |
| EstoniaPfizer Luxembourg SARL Eesti branches.: +372 666 7500 | AustriaPfizer Corporation Austria Ges.mbHPhone: +43 (0)1 521 15-0 |
| GreecePfizer Hellas AETel.: +30 210 6785 800 | PolishPfizer Polska Sp. z o. oTel.: +48 22 335 61 00 |
| SpainPfizer, SLPhone: +34 91 490 99 00 | PortugalLaboratórios Pfizer, Lda.Phone: +351 21 423 5500 |
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| CyprusPfizer Ελλάς Α.Ε. (Cyprus Branch)Phone: +357 22 817690 | United Kingdom (Northern Ireland)Pfizer LimitedPhone: +44 (0) 1304 616161 |
| LatviaPfizer Luxembourg SARL branch in LatviaTel.: + 371 670 35 775 |